Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01235806
First received: November 5, 2010
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

The Alpes Maritimes county administration (France) equipped Nice University Hospital of a 0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the medical imaging unit.

The aim of our project is to study its interest in diagnosis of scaphoid fractures.

Conventional medical care for patients being suspected to have a scaphoid fracture consists in performing a clinical examination and a radiographic check-up with at least 4 incidences, which 2 specific incidences for the scaphoid bone.

Yet, this check up is sometimes defective, causing false positives unnecessary immobilisation and false negatives delays in patient medical care, increasing the risk of complication. Those diagnosis mistakes can bring serious consequences, from permanent partial inability, to professional reclassification.

Alternative imaging exists, but is often irradiating, and never reaches the optimal specificity and sensitivity.

MRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of cases. The problem is the lack of accessibility for emergency cases; therefore there is a great interest in validating the use of a MRI dedicated to distal articulations.

The few studies that study costs of diagnosis strategies including MRI in scaphoid bone fractures diagnosis show a reduction of medical costs if this technique is used early. Our project represents an essential initial step in evaluating the impact of a low field MRI dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will be a medico-economical study, since scaphoid fractures occur frequently.

Finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.


Condition Intervention
Scaphoid Bone Fracture Suspicion
Radiation: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • MRI and radiography interpretation items [ Time Frame: The day of the scaphoid fracture ] [ Designated as safety issue: No ]
    comparaison between MRI and radiography interpretation items


Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Study Completion Date: January 2012
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MRI
MRI of the scaphoid bone fracture suspicion
Radiation: MRI
MRI of the scaphoid bone fracture suspicion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical suspicion of scaphoid bone fracture, whatever the radiologic check-up result is.
  • Major patient who signed the informed consent form.
  • Patient affiliated to French national health and pensions organization. NON INCLUSION
  • MRI contraindication.
  • No pain.
  • No traumatic antecedent.
  • Pregnant or suckler women.
  • Patient under a guardianship or a trusteeship
  • Patient deprived of liberty consequently to a judiciary procedure
  • Patient holding a pace-maker
  • Patient holding a foreign body or ferromagnetic prosthetic material.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235806

Contacts
Contact: Nicolas AMORETTI, MD amorettinicolas@yahoo.fr

Locations
France
Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital Recruiting
Nice, France, 06000
Contact: Nicolas Amoretti, MD       amorettinicolas@yahoo.fr   
Principal Investigator: Nicolas AMORETTI, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Nicolas AMORETTI, MD Medical and interventionnal Imaging Unit, Nice University Hospital
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01235806     History of Changes
Other Study ID Numbers: 07-CPR-01
Study First Received: November 5, 2010
Last Updated: December 8, 2011
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority
France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
scaphoid
MRI
ESAOTE

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 20, 2014